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taken phenobarbital, an ingredient in DONNATAL, and experienced restlessness and/or excitement instead of feeling calm.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING DONNATAL?: BEFORE YOU RECEIVE DONNATAL, TELL YOUR HEALTHCARE PROVIDER IF YOU:

are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. As DONNATAL can cause harm to your baby

are exposed to high temperatures as DONNATAL can cause overheating

have diarrhea as it may be an early symptom of other medical problems

have a stomach ulcer

experience drowsiness or blurred vision

take blood thinners

have a nerve disorder that affects the involuntary body functions

suffer from kidney or liver disease or liver problems

have an overactive thyroid

have heart disease, or have high blood pressure

have been or are addicted to any medication or have been dependent on drugs (phenobarbital, one of the ingredients in DONNATAL, can be habit forming)

have bile duct disease

have an aspirin sensitivity

have experienced a reaction to DONNATAL or any of its ingredients

WHAT ARE THE SIDE EFFECTS OF DONNATAL? WHEN USING DONNATAL YOU MAY HAVE SIDE EFFECTS.

DONNATAL may cause serious, even life threatening, allergic reactions.Stop taking DONNATAL and call your healthcare provider right away if you have any signs of a serious allergic reaction including: swelling, particularly of the eyelids, cheeks, or lips, and skin; and inflammation of the skin with redness. Call your healthcare provider if you have any of the following side effects:

Rarely, phenobarbital, an ingredient in DONNATAL, can cause a flaking type of skin reaction that can cause death. This may be associated with fever, changes in behavior, and changes in liver and other internal body parts.

Phenobarbital may produce excitement. In a few cases, anemia (affecting red blood cells) has resulted from long time use of phenobarbital. Seizures and confusion can occur if DONNATAL is stopped suddenly if you are dependent on sedatives such as phenobarbital.

Elderly persons may react with feelings of excitement, agitation, drowsiness, and other ill effects.

The risk information provided here is not comprehensive. To learn more, talk about DONNATAL with your healthcare provider or pharmacist. Click here to obtain the DONNATAL full prescribing information or call Concordia Pharmaceuticals Inc. at 1-877-370-1142.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.